Obstructive Sleep ApneaOSANCT07753785
Oliceridine Versus Sufentanil Analgesia for Postoperative Patients With Obstructive Sleep Apnea
An observational study of Obstructive Sleep Apnea and Postoperative Analgesia, run by Peking University First Hospital at 1 site in China.
Trial summary
Opioids are frequently used for postoperative analgesia but may induce side effects. Opioid-induced respiratory depression is the most dangerous side effect of opioids. Patients with obstructive sleep apnea (OSA) are at higher risk for opioid-induced respiratory depression. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Obstructive Sleep Apnea, Postoperative Analgesia, Oliceridine
- What is being tested?
- Oliceridine and Sufentanil
- Type of treatment
- Injection or infusion
- How many people
- 851 participants
- Where
- 1 siteChina
- Study dates
- Sep 2026to Dec 2029
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients with confirmed or suspected OSA who are scheduled to undergo noncardiac surgery and require patient-controlled intravenous analgesia after surgery.
Who may be able to join
- Aged 18 to 90 years.
- Diagnosed with obstructive sleep apnea according to polysomnography, or suspected to be at high risk of moderate-to-severe OSA according to the STOP-Bang questionnaire: (1) STOP-Bang score ≥ 5; (2) STOP-Bang score ≥ 3 with serum bicarbonate [HCO₃-] ≥ 28 mmol/L; (3) STOP score ≥ 2 and male sex; (4) STOP score ≥ 2 and body mass index (BMI) > 35 kg/m²; or (5) STOP score ≥ 2 and neck circumference > 40 cm.
- Scheduled to undergo elective non-cardiac surgery under general anesthesia.
- Required patient-controlled intravenous analgesia (PCIA) after surgery.
Who cannot join
- Pregnant or lactating women.
- Scheduled to undergo pulmonary/thoracic surgery in the current admission;
- Planning to receive use of epidural analgesia.
- Preplanned postoperative admission to the intensive care unit (ICU) or requirement for mechanical ventilation.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Peking University Fist Hospital
Beijing, 100034
Xue Li, MD, +86 18810527114, 3999165@163.com
About this study
Official title: Effects of Oliceridine Versus Sufentanil Analgesia on Incidence of Postoperative Respiratory Depression in Patients at High-Risk of Obstructive Sleep Apnea: A Prospective Cohort Study
Opioids are frequently used for postoperative analgesia but may induce side effects. Opioid-induced respiratory depression is the most dangerous side effect of opioids. Patients with obstructive sleep apnea (OSA) are at higher risk for opioid-induced respiratory depression. Oliceridine is a novel biased μ-opioid receptor agonist that selectively engages the G-protein pathway while reducing β-arrestin recruitment and thus may lower the risk of respiratory depression. The goal of this observational study is to compare the effects of oliceridine versus sufentanil analgesia on the incidence of postoperative respiratory depression in patients with known or suspected OSA in the postoperative period following elective surgery.
Read the detailed description
Postoperative acute pain affects up to 80% of surgical patients. Despite the increasing adoption of multimodal analgesia, opioids remain a mainstay for managing postoperative pain; however, their clinical utility is often constrained by dose-dependent adverse events that compromise recovery quality. Among these, opioid-induced respiratory depression is a serious and potentially fatal complication that may be substantially underestimated owing to its insidious presentation and limitations in routine monitoring. The reported incidence of opioid-induced respiratory depression ranges from 11% to 46%.
Obstructive sleep apnea (OSA) is a well-established risk factor for opioid-induced respiratory depression. Perioperative anesthetics exacerbate upper airway collapse and depress central respiratory while disrupted sleep architecture and intermittent nocturnal hypoxia heighten opioid sensitivity. Traditional μ-opioid agonists (e.g., morphine, fentanyl, sufentanil) activate both G-protein and β-arrestin pathways, producing effective analgesia but concurrently causing significant respiratory depression.
Oliceridine, a novel biased μ-opioid receptor agonist approved by the FDA in 2020, selectively engages the G-protein pathway while reducing β-arrestin recruitment, theoretically mitigating respiratory depression risk. Phase III trials and subsequent pooled analyses confirmed that oliceridine was associated with a lower respiratory event burden and fewer composite adverse events compared with morphine at equianalgesic doses. Recent data further supported its favorable respiratory safety profile and a wider safety margin in older patients. Nevertheless, regarding the incidence of respiratory depression, high-quality evidence comparing oliceridine with sufentanil for postoperative analgesia in patients who are diagnosed with or suspected to be at high risk of OSA remains limited.
This observational study aims to compare the incidence of respiratory depression within 24 hours postoperatively between oliceridine and sufentanil in surgical patients with confirmed or suspected OSA.
- Conditions
- Obstructive Sleep Apnea, Postoperative Analgesia, Oliceridine, Sufentanil, Respiratory Depression
- Being tested
- Oliceridine, Sufentanil
- Keywords
- Obstructive sleep apnea, Postoperative analgesia, Oliceridine, Sufentanil, Respiratory depression
- Medical subject headings
- Sleep Apnea, Obstructive, Respiratory Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OliceridineDrug
Oliceridine will be administered via patient-controlled intravenous analgesia.
SufentanilDrug
Sufentanil will be administered via patient-controlled intravenous analgesia.
| Study group | Role | What they receive |
|---|---|---|
| Oliceridine cohort | Patients will receive oliceridine via patient-controlled intravenous analgesia. Receives: Drug: Oliceridine | |
| Sufentanil cohort | Patients will receive sufentanil via patient-controlled intravenous analgesia. Receives: Drug: Sufentanil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of respiratory depression within 24 hours after surgery
Respiratory depression is defined as the occurrence of any of the following during the observation period:
- Respiratory rate ≤ 8 breaths/min, persisting for > 1 minute;
- SpO₂ ≤ 90%, persisting for > 1 minute;
- End-tidal CO₂ (EtCO₂) ≤ 15 mmHg or ≥ 60 mmHg, persisting for > 1 minute;
- Apnea > 30 seconds;
- Clinical situations requiring intervention: mask oxygenation (FiO₂ > 6 L/min) or high-flow nasal oxygen; insertion of oropharyngeal, nasopharyngeal, or supraglottic/subglottic airway devices; jaw thrust; non-invasive/invasive ventilation; administration of naloxone; unplanned ICU admission.
Measured: Within 24 hours after surgery
Secondary outcomes (3)
Quality of recovery on postoperative day 1
Quality of recovery will be assessed with the quality of recovery-15 (QoR-15; a 15-item questionnaire that evaluate the quality of early postoperative recovery after surgery and anesthesia. Scores range from 0 to 150, with higher scores indicating better quality of recovery）
Measured: On postoperative day 1.
Incidence of postoperative nausea and vomiting
Any event of nausea or vomiting
Measured: Within 72 hours after surgery
Area under curve (AUC) of pain intensity at rest and during movement
Pain intensity will be assessed with the numeric rating scale (NRS; an 11-point where 0=no pain and 10=the worst pain) at predefined time-points until 72 hours after surgery. The area under curve of pain intensity will be calculated using the trapezoidal rule.
Measured: Within 72 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2026
- Study startSep 2026 (estimated)
- Primary completionDec 2029 (estimated)
- Study completionDec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (21)Papers the sponsor has linked to this study.
- Other trials for Obstructive Sleep ApneaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 851 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University First Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dong-Xin Wang, Peking University First Hospital
- Investigators
- Dong-Xin Wang, MD, PhD, Study director, Peking University First Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07753785
- Sponsor's protocol ID
- 2026R0363
- Acronym
- OSA
- Status last verified
- Aug 2026
- First submitted
- 1 Aug 2026
- Last updated
- 11 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Practice Guidelines for the Prevention, Detection, and Management of Respiratory Depression Associated with Neuraxial Opioid Administration: An Updated Report by the American Society of Anesthesiologists Task Force on Neuraxial Opioids and the American Society of Regional Anesthesia and Pain Medicine. Anesthesiology. 2016 Mar;124(3):535-52. doi: 10.1097/ALN.0000000000000975. No abstract available.
PubMed 26655725Dahan A, Aarts L, Smith TW. Incidence, Reversal, and Prevention of Opioid-induced Respiratory Depression. Anesthesiology. 2010 Jan;112(1):226-38. doi: 10.1097/ALN.0b013e3181c38c25.
PubMed 20010421Yao X, Wang Z, Zhang Y, Jia W, Sheng X, Zhou Y, Xu C, Jiao H. Oxycodone versus Sufentanil for Postoperative Recovery in Obese Patients Undergoing Laparoscopic Bariatric Surgery: A Randomized Controlled Trial. Drug Des Devel Ther. 2025 Oct 17;19:9387-9397. doi: 10.2147/DDDT.S548173. eCollection 2025.
PubMed 41127367Sessler DI, Ayad S, Bakal O, Disher NS, Duran JA, Weingarten TN, Dahan A, Demitrack MA, Kim J, Khanna AK; VOLITION Study Team. Oliceridine for postoperative pain and opioid-related complications: The intravenous oliceridine and opioid-related complications (VOLITION) prospective cohort study. J Clin Anesth. 2025 Jul;105:111870. doi: 10.1016/j.jclinane.2025.111870. Epub 2025 May 29.
PubMed 40446423Simons P, van der Schrier R, van Lemmen M, Jansen S, Kuijpers KWK, van Velzen M, Sarton E, Nicklas T, Michalsky C, Demitrack MA, Fossler M, Olofsen E, Niesters M, Dahan A. Respiratory Effects of Biased Ligand Oliceridine in Older Volunteers: A Pharmacokinetic-Pharmacodynamic Comparison with Morphine. Anesthesiology. 2023 Mar 1;138(3):249-263. doi: 10.1097/ALN.0000000000004473.
PubMed 36538359Ayad S, Demitrack MA, Burt DA, Michalsky C, Wase L, Fossler MJ, Khanna AK. Evaluating the Incidence of Opioid-Induced Respiratory Depression Associated with Oliceridine and Morphine as Measured by the Frequency and Average Cumulative Duration of Dosing Interruption in Patients Treated for Acute Postoperative Pain. Clin Drug Investig. 2020 Aug;40(8):755-764. doi: 10.1007/s40261-020-00936-0.
PubMed 32583295Hammer GB, Khanna AK, Michalsky C, Wase L, Demitrack MA, Little R, Fossler MJ, Ayad S. Oliceridine Exhibits Improved Tolerability Compared to Morphine at Equianalgesic Conditions: Exploratory Analysis from Two Phase 3 Randomized Placebo and Active Controlled Trials. Pain Ther. 2021 Dec;10(2):1343-1353. doi: 10.1007/s40122-021-00299-0. Epub 2021 Aug 5.
PubMed 34351590Viscusi ER, Skobieranda F, Soergel DG, Cook E, Burt DA, Singla N. APOLLO-1: a randomized placebo and active-controlled phase III study investigating oliceridine (TRV130), a G protein-biased ligand at the micro-opioid receptor, for management of moderate-to-severe acute pain following bunionectomy. J Pain Res. 2019 Mar 11;12:927-943. doi: 10.2147/JPR.S171013. eCollection 2019.
PubMed 30881102Singla NK, Skobieranda F, Soergel DG, Salamea M, Burt DA, Demitrack MA, Viscusi ER. APOLLO-2: A Randomized, Placebo and Active-Controlled Phase III Study Investigating Oliceridine (TRV130), a G Protein-Biased Ligand at the mu-Opioid Receptor, for Management of Moderate to Severe Acute Pain Following Abdominoplasty. Pain Pract. 2019 Sep;19(7):715-731. doi: 10.1111/papr.12801. Epub 2019 Jun 24.
PubMed 31162798Markham A. Oliceridine: First Approval. Drugs. 2020 Nov;80(16):1739-1744. doi: 10.1007/s40265-020-01414-9.
PubMed 33025536Ramachandran SK, Haider N, Saran KA, Mathis M, Kim J, Morris M, O'Reilly M. Life-threatening critical respiratory events: a retrospective study of postoperative patients found unresponsive during analgesic therapy. J Clin Anesth. 2011 May;23(3):207-13. doi: 10.1016/j.jclinane.2010.09.003.
PubMed 21570616Gupta K, Nagappa M, Prasad A, Abrahamyan L, Wong J, Weingarten TN, Chung F. Risk factors for opioid-induced respiratory depression in surgical patients: a systematic review and meta-analyses. BMJ Open. 2018 Dec 14;8(12):e024086. doi: 10.1136/bmjopen-2018-024086.
PubMed 30552274Cozowicz C, Chung F, Doufas AG, Nagappa M, Memtsoudis SG. Opioids for Acute Pain Management in Patients With Obstructive Sleep Apnea: A Systematic Review. Anesth Analg. 2018 Oct;127(4):988-1001. doi: 10.1213/ANE.0000000000003549.
PubMed 29958218Turan A, You J, Egan C, Fu A, Khanna A, Eshraghi Y, Ghosh R, Bose S, Qavi S, Arora L, Sessler DI, Doufas AG. Chronic intermittent hypoxia is independently associated with reduced postoperative opioid consumption in bariatric patients suffering from sleep-disordered breathing. PLoS One. 2015 May 26;10(5):e0127809. doi: 10.1371/journal.pone.0127809. eCollection 2015.
PubMed 26010491Messineo L, Bakker JP, Cronin J, Yee J, White DP. Obstructive sleep apnea and obesity: A review of epidemiology, pathophysiology and the effect of weight-loss treatments. Sleep Med Rev. 2024 Dec;78:101996. doi: 10.1016/j.smrv.2024.101996. Epub 2024 Aug 30.
PubMed 39244884